UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 17, 2022, Talaris Therapeutics, Inc. announced its financial results for the quarter and year December 31, 2021 and other corporate updates. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit relating to Item 2.02 of this Form 8-K shall be deemed to be furnished and not filed:
Exhibit No. |
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Description |
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99.1 |
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Press Release issued by Talaris Therapeutics, Inc. on March 17, 2022. |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Talaris Therapeutics, Inc. |
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Date: |
March 17, 2022 |
By: |
/s/ Scott Requadt |
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Scott Requadt |
Exhibit 99.1
Talaris Therapeutics Announces Fourth Quarter and Year-End Financial Results and Provides Business Update
Phase 3 (FREEDOM-1) clinical trial in living donor kidney transplant (LDKT) patients continues; additional data update expected mid-year 2022
Two Phase 2 (FREEDOM-2 and FREEDOM-3) clinical trials of FCR001 initiated in delayed tolerance and scleroderma
Robust $244 million cash balance to fund operations through multiple milestones
BOSTON, MA, and LOUISVILLE, KY, March 17, 2022 – Talaris Therapeutics, Inc. (Nasdaq: TALS), a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune disorders, today reported financial results for the quarter and year ended December 31, 2021, and provided an update on its business.
“We are excited by what we were able to achieve in 2021 at Talaris,” stated Scott Requadt, Chief Executive Officer of Talaris. “The initial positive data update from our Phase 3 (FREEDOM-1) clinical trial that we provided late last year was a critical step that builds on years of research and development, and provides encouraging signs of FCR001’s potential to induce durable, drug-free immune tolerance in kidney transplant recipients. Inducing immune tolerance for patients without the challenges of taking life-long immunosuppressive drugs is widely seen as the “holy grail” in the transplant field. Taken together with the data from our Phase 2 study, we are encouraged by the body of supportive data that we have produced to date. We are keen to explore the extensibility of our therapy to additional patient populations, starting with our Phase 2 (FREEDOM-2) clinical trial of FCR001 in LDKT delayed tolerance induction and our Phase 2 (FREEDOM-3) clinical trial in our first severe autoimmune disease indication, scleroderma. We look forward to advancing all of our programs and providing additional updates on FREEDOM-1 in 2022.”
Recent Corporate Highlights
[1] Organ transplant population estimates based on UNOS/OPTN data for patients 1 year to 18 months delayed from incident LDKT
Fourth Quarter and Year-End 2021 Financial Results
About Talaris Therapeutics
Talaris Therapeutics, Inc. is a late-clinical stage cell therapy company developing therapies with the potential to transform the standard of care in solid organ transplantation and severe immune and blood disorders. Talaris maintains corporate offices in Boston, MA, its cell processing facility in Louisville, KY, and additional research operations in Houston, TX.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Talaris Therapeutics, Inc.’s (“Talaris,” the “Company,” “we,” or “our”) strategy, business plans and focus; the progress and timing of the preclinical and clinical development of Talaris’ programs, including FCR001 and FCR002; as well as expectations around timing and completion of clinical trial enrollment; expectations regarding the timing and data from the planned clinical update of FREEDOM-1, FREEDOM-2 or FREEDOM-3, including upcoming milestones and therapeutic effects; and expectations regarding Talaris’ use of capital, expenses and other financial results during 2021 and in the future. The words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “expect,” “estimate,” “seek,” “predict,” “future,” “project,” “potential,” “continue,” “target” or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks associated with: the impact of COVID-19 on countries or regions in which the Company has operations or does business, as well as on the timing and anticipated timing and results of its clinical trials, strategy and future operations, including the expected timing and results from FREEDOM-1, FREEDOM-2 and FREEDOM-3, the planned initiation and timing of IND-enabling studies of FCR001 and FCR002 in deceased donor transplants and the announcement of any additional indications for FCR001; the risk that the results of Talaris’ clinical trials, including the early data from the FREEDOM-1 study, may not be predictive of future results in connection with future clinical trials; the Company’s expectations regarding the potential urinary biomarker of immune quiescence, the Company’s ability to successfully demonstrate the safety and efficacy of its drug candidates; the timing and outcome of Talaris’ planned interactions with regulatory authorities; and obtaining, maintaining and protecting its intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the quarter and year ended December 31, 2021, as well as any subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Talaris’ views only as of today and should not be relied upon as representing our views as of any subsequent date. Talaris explicitly disclaims any obligation to update any forward-looking statements. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Media Contact
Lisa Raffensperger
Ten Bridge Communications
lisa@tenbridgecommunications.com
(617) 903-8783
Investor Contact
Chris Brinzey
Westwicke, an ICR Company
chris.brinzey@westwicke.com
(339) 970-2843
TALARIS THERAPEUTICS, INC (TALS)
Statements of Operations
(Unaudited, in thousands, except share and per share amounts)
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For the year ended December 31, |
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2021 |
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2020 |
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(in thousands) |
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Operating expenses |
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Research and development |
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$ |
34,245 |
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$ |
15,278 |
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General and administrative |
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$ |
13,262 |
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$ |
7,406 |
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Total operating expenses |
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47,507 |
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22,684 |
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Loss from operations |
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(47,507 |
) |
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(22,684 |
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Interest and other income (expense), net |
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$ |
(326 |
) |
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$ |
(23 |
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Net loss attributable to common stockholders |
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$ |
(47,833 |
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$ |
(22,707 |
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Net loss per common share, basic and diluted |
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$ |
(1.64 |
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$ |
(3.40 |
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Weighted average number of common shares outstanding used in |
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$ |
29,126,373 |
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$ |
6,685,066 |
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Balance Sheets Selected Financial Data
(Unaudited, in thousands)
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As of December 31, |
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2021 |
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2020 |
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Cash, cash equivalents and marketable securities |
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$ |
243,971 |
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$ |
149,488 |
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Working capital |
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238,527 |
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147,347 |
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Total assets |
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251,422 |
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152,778 |
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Other liabilities |
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626 |
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1,369 |
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Total liabilities |
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8,613 |
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4,774 |
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Total convertible preferred stock and stockholders’ deficit |
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242,809 |
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148,004 |
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